Iodent Sensitive Fresh Mint

Product NDC
65923-101
11-digit product format
659230101
Labeler code
65923
Product ID
65923-101_9fb471d5-d147-4a7a-8f57-0690e8249f36
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate and sodium floride
Dosage form
PASTE
Route
DENTAL
Labeler
United Exchange Corp.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-23
Marketing end
0000-00-00
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5 mg/100g; mg/100g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65923-101IInactivated by FDA2026-10-05
excluded packagepackage65923-10165923-101-13IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65923-101-13IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65923-101-13IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65923-101-13IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65923-101-13IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65923-101-13IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65923-101-13IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65923-101-13IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65923-101-13IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65923-101-13IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65923-101-13IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65923-101-13IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65923-101-13IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage65923-101-13IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage65923-101-13IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage65923-101-13IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage65923-101-13IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage65923-101-13IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage65923-101-13IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage65923-101-13IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage65923-101-13IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage65923-101-13IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage65923-101-13EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65923-101-132020-01-31C16284748780-19d75b9d0-707e-f424-e053-dadaa90a57cefc3514a3-7d58-495f-b14a-74b25416dc25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-101-13Iodent Sensitive Fresh Mint113 g in 1 TUBEPASTE1134
65923-101-13Iodent Sensitive Fresh Mint1 in 1 CARTONPASTE14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZIODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7IODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OIODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
NITRATE IONACTIVE MOIETYT93E9Y2844IODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311IODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9IODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
PEG/PPG-116/66 COPOLYMERINACTIVE INGREDIENTJP0CK963E0IODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQIODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYIODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZIODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
SORBITOLINACTIVE INGREDIENT506T60A25RIODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RIODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-101IODENT SENSITIVE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLORIDE) PASTE [UNITED EXCHANGE CORP.]4Legacy NDC, 2 package rows20161221_fc3514a3-7d58-495f-b14a-74b25416dc25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpastePSNfc3514a3-7d58-495f-b14a-74b25416dc254
1038841potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG ToothpasteSCDfc3514a3-7d58-495f-b14a-74b25416dc254
1038841K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSYfc3514a3-7d58-495f-b14a-74b25416dc254
1038841pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel ToothpasteSYfc3514a3-7d58-495f-b14a-74b25416dc254
1038841Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSYfc3514a3-7d58-495f-b14a-74b25416dc254
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpasteSYfc3514a3-7d58-495f-b14a-74b25416dc254

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
65923-101-1365923010113113 g in 1 TUBE113 gHistorical